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Risperidone in the treatment of acute mania

Double-blind, placebo-controlled study

The Psychiatric Clinic, Vasant Vihar, New Delhi, India

Eduard Vieta, MD

Department of Psychiatry, Hospital Clinic, University of Barcelona, IDIBAPS, Barcelona, Spain

Benjamin Lyons, PhD and Fred Grossman, DO

Johnson & Johnson Pharmaceutical Research and Development, Titusville, New Jersey, USA

Mariëlle Eerdekens, MD, MBA

Johnson & Johnson Pharmaceutical Research and Development, Beerse, Belgium

Michelle Kramer, MD

Johnson & Johnson Pharmaceutical Research and Development, Titusville, New Jersey, USA

Correspondence: Dr Sumant Khanna, The Psychiatric Clinic, 63 Paschmi Marg, Vasant Vihar, New Delhi, India. E-mail: sumantk_2002{at}yahoo.co.in

Declaration of interest B.L., F.G., M.E. and M.K. are employees of Johnson & Johnson Pharmaceutical Research and Development, which supported this study.

Background Severe mania is life-threatening, carries an increased risk of suicide and has a serious impact on patients and their families. Efficient and rapid control of episodes of acute mania is needed.

Aims To evaluate the safety and efficacy of risperidone monotherapy for acute mania.

Method In a 3-week, randomised, double-blind trial, 290 in-patients with bipolar I disorder with current manic or mixed episode and a baseline Young Mania Rating Scale (YMRS) score of 20 or more received flexible doses of risperidone (1–6 mg per day) or placebo.

Results Risperidone was received by 146 patients and placebo by144. Their mean baseline YMRS score was 37.2 (s.e.=0.5). Significantly greater improvements were observed with risperidone than with placebo at weeks 1 and 2 and at end-point (total YMRS: P <0.01). Extrapyramidal symptoms were the most frequently reported adverse events in the risperidone group.

Conclusions In patients with severe manic symptoms, risperidone produced significant improvements in YMRS scores as early as week 1 and substantial changes at end-point. Treatment was well tolerated.

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